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U.S. Department of Health and Human Services

Product Classification

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Device implant, endosseous, root-form
Regulation Description Endosseous dental implant.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeDZE
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.3640
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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